Various health care providers, such as anesthesiologists, anesthesiologist's assistants, medical doctors, nurses, and nurse's assistants, administer liquid pharmaceuticals and liquid nutrients to patients in a variety of different medical settings, such as in an intensive care unit (ICU), a critical care unit (CCU), an intensive treatment unit (ITU), a high dependency unit (HDU), an emergency room (ER), and the like. Health care providers also administer liquid pharmaceuticals and liquid nutrients to patients during a variety of medical procedures, such as, but not limited to, during surgery in an operating room or in an ICU. Health care providers may administer the liquid pharmaceuticals and liquid nutrients in a variety of different manners, such as: intravenously, such as through a central venous catheter (or central line); via an epidural; or via a subcutaneous injection.
To administer a liquid pharmaceutical and liquid nutrients to a patient intravenously, a health care provider often utilizes an intravenous (IV) bag containing that liquid pharmaceutical and those liquid nutrients, which are normally suspended in a carrying liquid or carrier (together referred to herein as the ‘intravenous (IV) solution’ for brevity). The IV bag typically has one or more permanent labels attached to the front and/or back surfaces of the bag that identify the IV solution contained in that IV bag. The permanent labels also include additional information about that IV solution, such as (but not limited to) the concentration of the pharmaceutical contained therein, the class of the pharmaceutical contained therein, and/or dosage guidelines of the pharmaceutical contained therein. The health care provider typically hangs the IV bag on an IV bag stand (such as an IV bag holder pole) located in close proximity to the patient (or in close proximity to the bed of the patient), and typically connects an IV tubing line connected to and extending from the IV bag to the patient in one of the variety of different manners mentioned above. After the IV bag is connected to the patient via the IV tubing line, the health care provider typically uses a drip chamber, a clamp, and/or an IV administration manifold system to control the flow of the IV solution into the patient.
In certain settings, such as in an ICU that houses a hospital's most critical patients, a typical patient is often simultaneously administered multiple different IV solutions intravenously at any given time. Typically, an ICU patient is administered between three and eighteen different IV solutions intravenously at any given time. It should be appreciated, however, that any suitable number of different IV solutions, such as three, five, ten, fifteen, twenty, or more different IV solutions, may be administered to a patient at any one time during treatment. Each of the IV solutions is usually contained in a different IV bag, and each of the IV bags is connected to a separate IV tubing line that, in turn, is connected to the patient. Thus, a typical ICU patient could have anywhere from three to eighteen (or more) IV tubing lines each running from a different IV bag to the patient. The number of IV bags connected to a patient may vary during the patient's stay in the ICU. For example, as the patient heals, the number of IV bags connected to the patient (i.e., the number of different IV solutions the patient needs) decreases. Since the IV bags are hung in close proximity to the patient on one or more IV bag stands, and thus in close proximity to one another, the IV tubing lines can intersperse with one another, often times resulting in a jumbled, tangled web of IV tubing lines, all of which are typically substantially similar in appearance.
This tangled web of similar IV tubing lines appears chaotic when compared to the otherwise orderly ICU. Specifically, since the ICU houses the hospital's most critical patients, the ICU is, by necessity, an extremely controlled environment. The strictly controlled ICU environment creates a relaxed or stress-reduced atmosphere or environment for the ICU patients, who are normally trying to recover from major accidents, major surgery, or other considerable ailments or health issues. To create such an atmosphere or environment, ICUs typically employ dim lighting relative to the standard harsh or bright fluorescent hospital lighting, and minimize noise by, for example, restricting visiting hours and restricting or eliminating the use of televisions.
While the ICU environment is strictly controlled in an attempt to reduce stress on patients, it is also strictly controlled to reduce the stress on ICU nurses and other health care providers. The critical nature of the patients housed in an ICU creates a stressful, complex, and chaotic environment in which the health care providers work. For example, health care providers must be ready and able to attend to any medical emergencies, which are likely to occur relatively frequently in the ICU due to the critical nature of the patients. To reduce this chaos and complexity, ICUs are extremely organized and ICU nurses are trained to keep the ICU as clutter free as possible. For example, medical instruments and other supplies are housed in certain specific locations, known to the health care providers, which enable them to perform both routine and emergency medical procedures and other tasks quickly and efficiently. This reduces the potential for complications to arise when medical procedures are performed in the ICU, such as by reducing the items that need to be regularly cleaned to prevent inventions from lingering bacteria.
The chaos created by the tangled web of IV tubing lines combined with the environment of the ICU makes working with the IV bags and IV tubing lines difficult or stressful for ICU nurses or other health care professionals. For instance, the nurse or nurses often must spend time untangling the IV tubing lines to determine which IV tubing line belongs to which IV bag when, for example, one or more of those IV bags needs to be changed. Since a patient connected to a large number of IV bags may need one or more of the IV bags changed at various times throughout each day, the nurse or nurses must perform this process several times every day. This is more problematic in emergency situations when time is of the essence. If, during a patient emergency, an IV bag must be disconnected or replaced, the nurse or nurses must wade through the web of IV tubing lines to ensure the nurse or nurses are removing the correct IV bag. This problem is worsened by the fact that the IV bags are hung in close proximity to one another, making it difficult for the nurse or nurses to read the permanent labels on the IV bags to differentiate the IV bags from one another and identify the IV solutions contained in those bags. The fact that the lighting in the ICU is dim and that the nurse or nurses must try to work quietly so as not to disturb or stress other patients further complicates these tasks.
The combination of these issues may lead to a nurse's failure to correctly identify an IV bag as containing a particular pharmaceutical, which could cause significant problems and complications for the patient. For example, if a certain IV bag containing an IV solution vital to a patient's stability (or possibly livelihood) is accidentally disconnected from the patient (because the nurse removes the wrong IV tubing line), the patient could suffer severe complications, setbacks to recovery, or even death. Even if the mistake is quickly realized, another IV bag must be connected, which can cause additional stress to an already fragile patient. Additionally, each time an IV bag is connected or unconnected to a patient, there is a risk of infection or other danger such as an air bubble entering the IV tubing line and, eventually, the patient. Unnecessary disconnections and reconnections of IV bags vastly increase these risks.
At least three known solutions that attempt to remedy these problems have been proposed, but each either fails to solve these problems and/or creates new problems.
U.S. Patent Application Publication No. 2002/0056989 to Lewis-Leander proposes one solution to these problems. Specifically, Lewis-Leander proposes affixing a main (i.e., permanent) label having a plurality of detachable labels to an IV bag. One entire side of each detachable label is printed with a single instance of the name of the IV solution contained in the IV bag. The other side of each detachable label includes an adhesive. After the main label is affixed to an IV bag, a user may remove one of the detachable labels by tearing it from the main label, and attach the detachable label to an IV tubing line connected to the IV bag by wrapping the detachable label around the IV tubing line such that the adhesive affixes the detachable label to the IV tubing line.
The Lewis-Leander proposed solution causes at least five additional problems. The first additional problem is that users, such as nurses or other health care providers, are reluctant to remove a portion of a permanent label on an IV bag. Nurses are trained not to destroy or alter permanent labels on IV bags because those permanent labels include vital information that may be critical to a patient's health and safety, and asking nurses to do so would contradict this training. Second, even if a nurse was willing to remove part of a permanent label on the IV bag, the permanent label on the IV bag can be damaged through the use of the Lewis-Leander proposed solution. For example, since the detachable labels must be torn off of the main label itself to be used (i.e., attached to the IV tubing line), it is possible that certain portions of the main label, and thus certain vital information, may be torn off of the main label along with the detachable labels, thereby rendering this information unavailable to the nurse.
The third additional problem created by the Lewis-Leander proposed solution is that it is difficult for a nurse to remove the detachable labels from the main label. As explained above, the main label is affixed to the IV bag, meaning that the detachable labels are positioned in close proximity to the IV bag. Due to the positioning of the main label and the detachable labels, the nurse must handle and manipulate the IV bag, which is full of an IV solution, to remove one or more of the detachable labels. This additional handling and manipulation of the IV bag increases the possibility that the IV bag will be ripped, punctured, or otherwise contaminated and rendered useless during the process of removing the detachable labels from the main label.
The fourth additional problem is that the Lewis-Leander proposed detachable labels do not provide the health care provider any cues, visual or otherwise, to remove the detachable labels from the main label. Since the detachable labels are attached to the main label and, therefore, positioned in close proximity to the IV bag, it appears upon first glance that the detachable labels are simply part of the main label and used to identify the IV bag itself as containing the IV solution. There is nothing that prompts the nurse to reach out and detach one or more of the Lewis-Leander detachable labels. The fifth additional problem created by the Lewis-Leander proposed solution stems from the fact that the detachable labels are opaque. When these opaque detachable labels are wrapped around an IV tubing line, the nurse is not able to view the IV solution flowing through that section of the IV tubing line. This is problematic because the nurse will not be able to see whether there are any issues within that section of the IV tubing line, such as a blockage.
In addition, the Lewis-Leander proposed solution does not solve all of the problems explained above that stem from the tangled web of IV tubing lines. Specifically, since each detachable label includes a single instance of an IV solution name (or the name of the pharmaceutical therein) printed across the entirety of only one side of that detachable label, when that detachable label is wrapped around an IV tube, the entire IV solution name is not visible or readily readable unless the nurse manipulates and repositions the detachable label (to read the entire name). That is, the use of the Lewis-Leander proposed solution would still require a nurse to handle and manipulate the IV tubing lines (with the detachable label or labels attached thereto) to determine which tubing line contains which IV solution. It is likely for this reason, and because of the five additional problems discussed above, that the Lewis-Leander proposed solution has not been commercially implemented.
System One Medical provides another proposed solution in the form of a roll of opaque labels. One side of each label includes an adhesive covered by a liner, and the other side includes a blank space in which the name of an IV solution may be written by a nurse (or other health care provider) or printed using a thermal printer. Prior to attaching one of the labels to an IV tubing line, the nurse must write on the blank label the name of the IV solution (or the name of the pharmaceutical therein) in an IV bag to which the IV tubing line is connected. The nurse then removes the liner and uses the adhesive to attach that label to the IV tubing line by wrapping the adhesive portion of the label around the IV tubing line. The System One Medical proposed solution fails to remedy the fourth and fifth problems inherent in the Lewis-Leander proposed solution discussed above. Specifically, the labels of the System One Medical proposed solution are also opaque, and since the labels of the System One Medical proposed solution are not initially attached to any IV bags, they do not provide any visual cues to the nurse to use the labels. That is, when the nurse views the IV bag, such as when the nurse initially sets up the IV bag, there are no cues that remind the nurse to utilize the labels.
Additionally, the labels of the System One Medical proposed solution require the nurse to take multiple additional steps and use multiple additional tools and materials during preparation of an IV bag and its corresponding IV tubing line. Namely, the System One Medical proposed solution requires the nurse to locate the roll of blank labels, write out the name of an IV solution on the label using a pen, detach the label from the roll, and attach the label to the IV tubing line. These additional steps are inconvenient, especially when the nurse is pressed for time in an emergency, and may deter the use of the labels. Further, the fact that the nurse must write the IV solution name on the label introduces the possibility of human error if, for example, the nurse writes the incorrect IV solution name, misspells the IV solution name, or writes a confusing abbreviation of the IV solution name. Also, certain nurses may not be able to read the handwriting of other nurses, or the ink used to write on the labels may smear or bleed. That is, the System One Medical labels are not waterproof. Further, the labels of the System One Medical proposed solution are not rigid, and may curl or otherwise deform after attachment, making it difficult for the nurse or nurses to read the IV solution name written on the tag. More specifically, at times, nurses monitor ICU patients by watching the patients through glass monitoring windows in the ICU. This enables nurses to determine whether a patient's IV bag is low or empty without having to enter the ICU and disturb the patient or any of the other patients. Since the System One Medical labels are not rigid and may curl, the nurses may not be able to view the labels through the monitoring windows and identify the IV solution in the low or empty IV bags. The nurse would have to enter the ICU to make that determination, potentially disturbing patients.
Another proposed solution that is somewhat utilized involves a nurse or nurses using a piece of a roll of tape to identify IV tubing lines. To identify an IV tubing line in this manner, a nurse: (a) locates a roll of white cloth, paper, or plastic medical tape; (b) uses scissors to cut a piece of tape from the roll or tears a piece of tape from the roll; (c) uses a pen to write the name of an IV solution on the piece of tape; and (d) wraps the piece of tape around an IV tubing line connected to an IV bag containing that IV solution. Nurses often do this two or three times to attach pieces of tape to multiple spaced apart spots on each IV tubing line. The medical tape proposed solution suffers from the same problems as the System One Medical proposed solution. Namely, the medical tape proposed solution involves using opaque tape and provides no visual cues to the nurse to use the tape in such a manner. Also, the tape is not rigid, and may deform or curl, making reading the written IV solution name difficult. This could also cause nurses to not be able to read the written IV solution name through an ICU monitoring window, as described above. The possibility for human error is high in this system is well. For example, nurses may write the incorrect IV solution name, nurses may not be able to read one another's handwriting, and nurses may use abbreviations of IV solution names that are confusing or unrecognizable to others. Further, there is a possibility that the ink used in the medical tape proposed solution could bleed or smear (similar to the System One Medical labels). Additionally, the adhesive on the tape is not medical grade adhesive, and may leach through the IV tubing line and make its way into the IV solution. Thus, the medical tape proposed solution increases the risk that the IV solution could become contaminated while being administered to the patient.
Additionally, the medical tape proposed solution requires a considerable amount of time and effort and, like the System One Medical proposed solution, requires additional materials, such as a pen, tape, and scissors. The medical tape proposed solution thus diverts a nurse's attention away from the critical patients while they spend time preparing a number of pieces of tape. The additional materials required also clutter the ICU, and provide more surfaces for bacteria and other infectious agents to grow, thereby exposing the patients to possible infection and possibly contaminating the otherwise clean ICU environment.
Accordingly, there is a substantial need to provide an IV bag/line safety device that does not interfere with permanent labeling on IV bags, that is easy to use, that provides cues that remind a health care professional to use the safely device, that requires minimal additional work on the part of the health care professional, that maintains or increases patient safety, that aids in maintaining the environment of the ICU, and that reduces the potential for human error.